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Effectiveness and toxicity of lenvatinib in refractory thyroid cancer: Dutch real-life data

Aydemirli, M. D., Kapiteijn, E., Ferrier, K. R. M., Ottevanger, P. B., Links, T. P., van der Horst-Schrivers, A. N. A., Broekman, K. E., Groenwold, R. H. H. & Zwaveling, J., Feb-2020, In : European Journal of Endocrinology. 182, 2, p. 131-138 8 p.

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  • Effectiveness and toxicity of lenvatinib in refractory thyroid cancer_ Dutch real-life data

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Objective: The SELECT trial showed progression-free survival (PFS) benefit for lenvatinib for advanced radioiodine-refractory differentiated thyroid cancer (RAI-refractory or RR-DTC) patients, on which current clinical practice is based. We assessed whether the effectiveness and toxicity of lenvatinib in real-life clinical practice in the Netherlands were comparable to the pivotal SELECT trial.

Methods: From three Dutch centres Electronic Health Records (EHRs) of patients treated in the lenvatinib compassionate use program or as standard of care were reviewed and checked for SELECT eligibility criteria. Baseline characteristics, safety, and efficacy measures were compared and PFS and overall survival (OS) were calculated. Furthermore, PFS was compared to estimates of PFS reported in other studies.

Results: A total of 39 DTC patients with a median age of 62 years were analysed. Of these, 27 patients (69%) did not fulfil the SELECT eligibility criteria. The most common grade >= 3 toxicities were hypertension (n = 11, 28%), diarrhoea (n = 7, 18%), vomiting (n = 4, 10%), and gallbladder disease (n = 3, 8%). Median PFS and median OS were 9.7 (95% confidence interval (CI): 4.0-15.5) and 18.3 (95% CI: 4.9-31.7) months, respectively, response rate was 38% (95% CI: 23-54%). PFS in the Dutch real-life situation was comparable to previous real-life studies, but inferior to PFS as shown in the SELECT trial (P = 0.04).

Conclusions: PFS in our non-trial population was significantly shorter than in the SELECT trial population. In the interpretation of results, differences in the real-life population and the SELECT study population regarding patient characteristics should be taken into account.

Original languageEnglish
Pages (from-to)131-138
Number of pages8
JournalEuropean Journal of Endocrinology
Volume182
Issue number2
Publication statusPublished - Feb-2020

    Keywords

  • Adult, Aged, Aged, 80 and over, Antineoplastic Agents/therapeutic use, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Phenylurea Compounds/adverse effects, Quinolines/adverse effects, Retrospective Studies, Thyroid Neoplasms/drug therapy

ID: 116876223